The goal of this Phase I SBIR proposal is to develop a navigation and image fusion system for improved diagnosis of cervical cancers and pre-cancers. The system will combine optical coherence tomography (OCT) imaging with traditional colposcopy (with or without aceto-whitening) and/or fluorescence imaging to allow highly detailed morphological analysis of suspicious regions. These two complimentary imaging systems will be combined through real-time three-dimensional spatial tracking of a small endoscope-like OCT imaging probe. Once the location of the cervix is known relative to the frame of the 3D tracking system and an acquired cervical image (e.g. from colposcope) has been registered, software will continually update the position of the OCT probe on the cervical image providing registration between macro imaging and OCT image data and providing guidance to the OCT operator for exploration of suspicious regions. This same co-registration may also be useful for creating wide-field volume data sets based on manually scanned video-rate OCT acquisition, and we will test this hypothesis as well. During this project, we will develop a proof-of-concept prototype which will be characterized and tested in phantoms and demonstrated in an ovine cervicovaginal model. PUBLIC HEALTH RELEVANCE: In 2008, approximately 11,070 cases of invasive cervical cancer are expected to be diagnosed in the United States, and it is estimated that incidence of noninvasive cervical cancer (carcinoma in situ) is about four times as high [http://www.cancer.gov/cancertopics/types/cervical]. Approximately 3,870 women are expected to die from cervical cancer in the United States during 2008. Though mortality rates associated with cervical cancer have decreased dramatically over the last 50 years, the incidence of cervical precancers has increased, and it has been suggested that without improvement in current screening and diagnostic techniques, mortality rates associated with cervical carcinoma could increase, especially if human papilloma virus (HPV) seroprevalence continues to rise. Early detection of cervical precancerous lesions can have a dramatic impact on cervical cancer mortality rates, increasing five- year survival rates from 70% to about 100%. This project focuses on development of a novel imaging system for improving diagnosis and characterization of cervical tissue.